Analysis of CA-MRSA Transmission: An ED Population Sampling Strategy

August 19, 2024 updated by: University of Florida

Molecular Epidemiology and Phylodynamic and Phylogeographic Analysis of Community-associated Methicillin-resistant Staphylococcus Aureus (CA-MRSA) Transmission: An Emergency Department Population Sampling Strategy

Given that the Emergency Department (ED) has become the entry way for large populations of patients into the health care system, a strategy of sampling MRSA isolates in ED populations and merging this information with patient-level data may present a window to hypothesize and investigate CA-MRSA transmission within the community and its impact on hospital-acquired infections.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Prospective cross-sectional study involving 500 patients enrolled over a one year period at the UFHealth Shands Hospital's Adult and Pediatric Emergency Department. The collected information will serve as pilot data for a future large comprehensive multi-site study.

Patients will have a wound culture and a nasal swab obtained as part of the study, which will be assessed for MRSA isolates using next-generation whole genome sequencing. The principal investigator or PI designee will also survey participants and review hospital records.

Study Type

Observational

Enrollment (Actual)

575

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Florida
      • Gainesville, Florida, United States, 32608
        • UF Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult and pediatric patients presenting to the UFHealth Shands Emergency Department with evidence of an acute abscess, or skin/soft tissue infection (SSTI), which can be sampled for culture and sensitivity testing

Description

Inclusion Criteria:

  • Patient or Legally Authorized Representative (LAR) must have voluntarily signed an Institutional Review Board-approved informed consent form before initiation of any study procedures
  • Patient presents with an acute abscess or a non-post-operative skin/soft tissue infection
  • Patient presents through the UFHealth Shands Emergency Department

Exclusion Criteria:

  • Patients who are employed by UFHealth and provide direct patient care
  • Patients who have previously been enrolled in the study
  • Patients who are not suitable for the study in the opinion of the investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Acute Abscess Group
Adults and pediatric patients presenting to the UFHealth Shands Emergency Department with evidence of an acute abscess, or skin/soft tissue infection, which can be sampled for culture and sensitivity testing will be recruited.
Samples collected for culture and sensitivity testing depending on acute abscess, or skin/soft tissue infection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Strain Relatedness Identification Through Phylogenetic Analysis
Time Frame: 1 Hour
Molecular (spa-typing) and genomic (WGS) relatedness of MRSA strains in isolates in ED populations presenting with SSTIs.
1 Hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Strain Transmission Through Analysis of Genetic Clustering
Time Frame: 1 year
Phlyodynamic analysis of MRSA transmission course by strain
1 year
Patient Level Characteristics of Skin and Soft Tissue Infection (SSTI) Presentation
Time Frame: 6 Months
To determine patient-level characteristics, including social and medical history, associated with a presentation related to SSTIs.
6 Months
Pediatric and Adult Population Presentation Characteristics in Skin and Soft Tissue Infection (SSTI)
Time Frame: 6 Months
Compare patient-level characteristics and phylogenetic clustering between pediatric and adult patients presenting with SSTIs.
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Joseph A Tyndall, MD, University of Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2015

Primary Completion (Actual)

April 4, 2018

Study Completion (Actual)

April 4, 2018

Study Registration Dates

First Submitted

February 9, 2015

First Submitted That Met QC Criteria

February 9, 2015

First Posted (Estimated)

February 13, 2015

Study Record Updates

Last Update Posted (Actual)

August 21, 2024

Last Update Submitted That Met QC Criteria

August 19, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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